medical MODERATE
Fish
Updated 2026-06-24

Staar Surgical AG recalls Product Name: STAAR ICL Calculation Software Software Versi

See all recalls from Staar Surgical AG →

Recalled Product

Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR ICL Calculation Software is designed as an aide in the calculation of the size and diopter power (with residual refraction) for physician selection of the lens. For toric ICLs, an Implantation Orientation Diagram (IOD) is also produced to provide the physician with pictorial representation of the axis of rotation and alignment. Note: The STAAR ICL Calculation Software resides on STAAR Surgical's e-commerce website in STAAR ICL planning support (Stella), as referenced in the attached recall communication. Component: No

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: UDI (01)00840311346288(0812)8.00 Software Version 8.00 The software error occurs if a customer generated an IOD for a toric implantation from April 13, 2026 to April 16, 2026 for multiple toric lens reservations for the same eye using the STAAR ICL Calculation Software.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Product Name: STAAR ICL →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

Related medical Recalls

Medline Industries, LP recalls Medline convenience kits: PORT A CATH DYNJ906818A

2026-06-24 · Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Medline Industries, LP recalls Medline convenience kits: LOOP PACK DYNJ61460C OPEN H

2026-06-24 · Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Beta Bionics, Inc. recalls iLet Bionic Pancreas, REF: BB1001

2026-06-24 · The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia.

Medline Industries, LP recalls Medline convenience kits: 20CM CVC INSERTION KIT ECVC680

2026-06-24 · Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.